N/A
Completed N=649
Prevenar13 Post Market Surveillance
Healthy
Source: ClinicalTrials.gov NCT01509105 ↗
Enrolled (actual)
649
Serious AEs
0.5%
Results posted
Feb 2017
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 — 68; 1 participants
Summary
It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 |
68; 1 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 |
67; 0 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 |
52; 2 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 |
43; 0 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 |
37; 0 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 |
30; 0 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 |
13; 0 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 |
17; 0 | — |
| SECONDARY Duration of Adverse Events (AEs) |
7.21 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) by Severity |
66; 4; 0; 64; 4; 0 | — |
| SECONDARY Number of Participants With Outcome in Response to Adverse Events (AEs) |
1; 1; 164 | — |
| SECONDARY Number of Participants Discontinued Due to Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).
Exclusion Criteria
- Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Data sourced from ClinicalTrials.gov (NCT01509105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.